Therapeutic thermal compress with phase-change material

ABSTRACT

A therapeutic device such as an eye mask or compress for delivery of moist heat therapy to a body part such as an eye of a human or animal subject. Example devices are configured to be worn with one or more eye coverage portions positioned over the subject&#39;s eye(s). The eye coverage portions have a front side configured for placement against the treated body part, and a back side opposite the front side. The eye coverage portions include recesses or retracted sections configured to be positioned over the wearer&#39;s cornea area. The shell of the eye coverage portions may further incorporate antimicrobial properties. Heat transfer mediums or fill materials can include hydrophilic zeolite, silica gel, and/or one or more phase change materials so as to provide controlled performance characteristics.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 62/871,801 filed Jul. 9, 2019. This application is also acontinuation-in-part of U.S. Non-Provisional patent application Ser. No.16/366,310 filed Mar. 27, 2019. U.S. Non-Provisional patent applicationSer. No. 16/366,310 is a continuation-in-part of U.S. Non-Provisionalpatent application Ser. No. 16/202,879 filed Nov. 28, 2018, which claimspriority to U.S. Provisional Patent Application Ser. No. 62/591,929filed Nov. 29, 2017. U.S. Non-Provisional patent application Ser. No.16/366,310 is also a continuation-in-part of U.S. Non-Provisional patentapplication Ser. No. 16/107,200 filed Aug. 21, 2018, which is acontinuation-in-part of U.S. Non-Provisional patent application Ser. No.15/443,199 filed Feb. 27, 2017, which claims priority to U.S.Provisional Patent Application Ser. No. 62/301,999 filed Mar. 1, 2016,and to U.S. Provisional Patent Application Ser. No. 62/430,430 filedDec. 6, 2016. U.S. Non-Provisional patent application Ser. No.16/107,200 claims priority to U.S. Provisional Patent Application Ser.No. 62/548,774 filed Aug. 22, 2017. U.S. Non-Provisional patentapplication Ser. No. 16/366,310 is also a continuation-in-part of U.S.Non-Provisional patent application Ser. No. 15/443,199 filed Feb. 27,2017, which claims priority to U.S. Provisional Patent Application Ser.No. 62/301,999 filed Mar. 1, 2016, and to U.S. Provisional PatentApplication Ser. No. 62/430,430 filed Dec. 6, 2016. All of theseapplications are hereby incorporated herein by reference.

TECHNICAL FIELD

The present invention relates generally to the field of hot or coldthermal therapy, such as for example ophthalmic medical therapy orpalliative care of the eye or other body part of a human or animalsubject by application of thermal therapy with a therapeutic thermalcompress. More particularly in example embodiments, the presentinvention relates to a mask or compress for thermal treatment and/ordelivery of medication to the eyes, and surrounding sinus and facialareas of a subject or patient. In further example embodiments, a thermaltherapeutic compress may be configured and provided for application tothe neck, back, or other body part. In particular applications,embodiments of the invention further relate to a moist heat deliverydevice with heat-loss preventive structures, thermal protectivemeasures, and/or antimicrobial properties. In further exampleembodiments, a phase-change material is incorporated into a thermaltherapy compress for sustained thermal therapy within a desiredtemperature range for an extended period of time.

BACKGROUND

Various conditions of the eye may require medical or palliative care.For example, blepharitis is a common and ongoing condition where theeyelids become inflamed (swollen), with oily particles and bacteriacoating the eyelid margin near the base of the eyelashes. This conditioncauses irritation, itchiness, redness, dry eye and stinging or burningof the eyes. While the underlying causes of blepharitis are notcompletely understood, it can be associated with a bacterial eyeinfection, symptoms of dry eyes or certain types of skin conditions suchas acne rosacea. Anterior blepharitis affects the outside of the eyelidwhere the eyelashes are attached. This can be caused by bacterial (orsometimes viral) infection. If left untreated, anterior blepharitis canlead to thickened and inward-turned or outward-turned eyelids and evenvision problems from in-turned eyelashes damaging the cornea. Posteriorblepharitis is a condition that results from a dysfunction of the eye'stiny oil glands (meibomian glands) in the eyelids at the base of theeyelashes. When meibomian glands become clogged from posteriorblepharitis, it can cause a stye or chalazion to form. Posteriorblepharitis can also lead to thickened eyelid margins and crustyeyelids.

An estimated 40.9 million people in the United States aged 18 or olderwear contact lenses. The International Workshop on Contact LensDiscomfort, published in 2013, put forth dryness of the eyes as aprimary reason for contact lens intolerance. When a contact lens isplaced on the eye, the tear film structure becomes altered resulting ina pre-lens thinned lipid layer and a post-lens thinned aqueous layer. Asa result of this disruption from the contact lens, the tear film tendsto have an increased rate of evaporation leading to poor wetting on thesurface of the contact lens and inadequate lubrication on the surface ofthe eye. This is further exacerbated if the patient has an alreadyunstable lipid layer due to the presence of meibomian gland dysfunction(MGD). MGD is considered by many to be the leading cause of dry eyedisease throughout the world and is a chronic and progressive conditionthat can contribute to a poor quality lipid layer and lead to contactlens discomfort. Contact lens wearers often report dry eye symptoms andshow signs of MGD including gland atrophy, thinned lipid layer, andincreased tear film instability. It has been shown that in many patientswith intolerance to contact lenses, MGD has been observed. Therefore,treatment of MGD may support the functioning of the meibomian glands andlead to improvement in patient contact lens comfort.

Hygienic home treatment of such ocular disorders can be a two-stepprocess. First, the patient softens the debris and scurf thataccumulates around the eye. The debris can be softened by applying awarm compress, diluted baby shampoo, or a specialized liquid solution tothe eyelid margin. This first step is intended to prepare the debris forremoval while preventing further irritation to the eye. Second, thepatient can attempt to remove the debris by physically scrubbing theeyelid margin, the base of the eyelashes, and the pores of the meibomianglands. This scrubbing is routinely attempted with either a genericcotton swab, a fingertip, or a scrub pad placed over the fingertip andapplied against the eye. By cleaning debris and scurf free from the baseof the eyelashes and unclogging the pores of the meibomian glands, thepatient may improve the overall health of the eyelid margin; therebyreducing irritation, burning, and other symptoms related to thedisorder.

Thermal therapy can also be used for medical or palliative care of ahuman or animal subject or patient, for example by delivering moist heator cold to the eye region. In example applications, thermal therapy canbe used to unblock glands in the eye to help treat dry eye. Moist heatmay also be used to help reduce elevated intraocular pressure to eithertreat or help prevent open-angle glaucoma. Delivery of medications tothe eyes, such as for treatment of blepharitis may be enhanced byapplication of thermal therapy in combination with the medication.Applying heat to the inner eyelid may also help safely remove glandobstructions and stagnant gland content. Moist heat thermal therapy ofthe eyes may also be beneficial to extend comfortable wearing time ofcontact lenses.

Many currently known eye treatment masks are not designed to securelyfit the eye, causing issues in some forms of therapeutic treatment. Forexample, when a patient uses a continuous positive airway pressure(CPAP) machine for treatment of sleep apnea, air can sometimes blowbackfrom the mask of the CPAP machine into the user's eyes, causing drynessof the eyes. Known eye masks and eye compresses may not fit securely tothe eye and have not been found entirely successful in protecting theeyes from this blow-back dryness.

In other instances, it is desirable to maintain a relatively steadytemperature (i.e., within a specified temperature range) for an extendedperiod of time during thermal (hot or cold) therapy by application of athermal therapeutic compress to a body part (back, neck, eye, head, arm,leg, torso, foot, ankle, knee, hip, shoulder, elbow, wrist, hand, orother body part). Many known therapeutic compresses are not capable ofsustaining a therapy temperature for sustained periods desired for suchtreatment.

Needs exist for improvements to ophthalmic medical therapy or palliativecare of the eye. Further needs exist for improvements to thermaltherapeutic compresses to allow longer-term sustained thermal treatmentwithin a specified temperature range. It is to the provision improvedtherapeutic eye mask system and treatment methods meeting these andother needs that the present invention is primarily directed.

SUMMARY

In example embodiments, the present invention provides a therapeuticmask or compress system for treatment of the eyes, generally includingat least one, and in particular embodiments two separate eye coverageportions, wherein each of the eye coverage portions is configured todeliver moist heat therapy to the eye area of a human or animal patient.The mask is configured to be worn on the head of the patient with one ofthe eye coverage portions positioned over at least one eye, and inparticular embodiments with eye coverage portions positioned over botheyes of the patient.

In example embodiments of the invention, the eye mask or compresscomprises at least one eye coverage portion, at least one securing strapattached to the eye coverage portion(s) for securing the eye coverageportion(s) over the eye of the patient, and a fill material enclosedwithin each eye coverage portion. The eye coverage portions are formedfrom a moisture-permeable material comprising antimicrobial propertieswherein the fill material is configured to absorb and release moisturethrough the moisture-permeable material. Each eye coverage portion has afront side, configured to rest against the face of the patient incontact with the area around one or both of the user's eyes, and a backside opposite the front side directed away from the user. In exampleembodiments, each eye coverage portion also includes a generallycentrally located dimple or recess on the front side or both sides,forming a retracted non-contact area configured allow space between thecompress and the eye area of the subject, to prevent the application ofexcessive heat on and around the cornea, preventing conditions such ascorneal warping, while allowing moist heat therapy to reach the eyelidand surrounding eye area.

In another aspect, the invention relates to an eye compress for deliveryof moist heat to a patient. In example forms, the eye compress includesat least one enclosure containing a fill material capable of absorbingand releasing moist heat for therapeutic delivery to the patient, theenclosure having a first side and an opposite second side, with the fillmaterial disposed between the first and second sides, and wherein thefirst side is configured for application to an eye or other body portionof the patient. In example embodiments, the eye compress also includes astitched or sutured segment joining the first side and the second side,wherein the stitched segment is configured to be positioned over acornea of the eye of the patient, to prevent application of excess heattransmission from the fill material to the cornea of the patient oruser.

In still another aspect, the invention relates to a method of providingmoist heat therapy to an eye area of a human or animal subject. Inexample forms, the method includes providing a therapeutic devicecomprising at least one eye cover enclosure with a first side and asecond side, a seam or stitched segment joining together the first andsecond sides to form a recessed non-contact area, and a hydrophilic fillmaterial contained within the first and second sides of the eye coverenclosure. The first side of the eye cover enclosure at least partiallycomprises a moisture-transmissive material allowing passage of moisturetherethrough for absorption into and release from the fill material. Thestitched segment is configured to be positioned over the cornea of theeye of the human or animal subject to prevent excessive heat exposure tothe cornea. Additionally, in example embodiments the eye cover enclosureat least partially comprises antimicrobial material.

In still another aspect, the invention relates to thermal therapeuticsystems, apparatus, devices and methods for maintaining a relativelysteady temperature (i.e., within a specified temperature range) for anextended period of time during thermal (hot or cold) therapy byapplication of a thermal therapeutic compress to a body part (back,neck, eye, head, arm, leg, torso, foot, ankle, knee, hip, shoulder,elbow, wrist, hand, or other body part). In example embodiments, atherapeutic compress capable of sustaining a therapy temperature forsustained periods is provided. In particular embodiments, a thermaltherapy compress incorporating one or more phase-change materials isprovided.

These and other aspects, features and advantages of the invention willbe understood with reference to the drawing figures and detaileddescription herein, and will be realized by means of the variouselements and combinations particularly pointed out in the appendedclaims. It is to be understood that both the foregoing generaldescription and the following brief description of the drawings anddetailed description are exemplary and explanatory of preferredembodiments of the invention, and are not restrictive of the invention,as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a therapeutic eye mask system accordingto an example embodiment of the invention.

FIG. 2 shows a back view of the therapeutic eye mask system depicted inFIG. 1.

FIG. 3 shows the therapeutic eye mask system depicted in FIG. 2including detachable pods.

FIGS. 4A-C show a front, back and side view of the therapeutic eye masksystem of FIG. 1.

FIG. 5 is a perspective view of a therapeutic eye mask system accordingto another example embodiment of the invention.

FIG. 6 shows a back view of the therapeutic eye mask system of FIG. 5.

FIGS. 7A-C show a front, back and side view of an eye mask portion foruse in a therapeutic eye mask system according to another exampleembodiment of the invention.

FIGS. 8A-C show a front, top and side views of a therapeutic eye masksystem with the eye mask portion of FIGS. 7A-C.

FIG. 9 shows the therapeutic eye mask of FIG. 1 worn by a human patient.

FIG. 10 shows the therapeutic eye mask of FIGS. 8A-C worn by a humanpatient.

FIGS. 11A-B show the therapeutic eye mask of FIGS. 8A-C worn by a humanpatient.

FIG. 12 shows a therapeutic eye mask system according to another exampleembodiment of the invention.

FIG. 13 is an exploded view of a therapeutic eye mask system accordingto another example embodiment of the invention, having interchangeablepods.

FIG. 14 shows a detailed exploded view of the therapeutic eye masksystem of FIG. 13.

FIG. 15 shows a detachable pod for use in a therapeutic eye maskaccording to an example embodiment of the invention.

FIG. 16 shows a detachable pod according to another example embodimentof the present invention.

FIG. 17 shows detachable pods of varying shapes according to furtherexample embodiments of the invention.

FIG. 18 shows detachable pods of varying sizes according to exampleembodiments of the invention.

FIG. 19 shows a therapeutic eye mask system according to an exampleembodiment of the invention.

FIG. 20 shows a therapeutic eye mask system according to an exampleembodiment of the invention.

FIG. 21 is a perspective view of a therapeutic eye mask system accordingto another example embodiment of the invention.

FIG. 22 shows a side view of the therapeutic eye mask system of FIG. 21.

FIG. 23 shows a back view of the therapeutic eye mask system of FIG. 21.

FIG. 24 is a cut-away view of a pod of the therapeutic eye mask systemof FIG. 21.

FIG. 25 shows heat-transmissive pads for use with a therapeutic eyemask.

FIG. 26 shows a side exploded view of a therapeutic eye mask system withheat-transmissive pads.

FIG. 27 shows a therapeutic eye mask system according to another exampleembodiment of the present invention worn by a human patient.

FIG. 28 shows a therapeutic eye mask system according to yet anotherexample embodiment of the present invention.

FIG. 29 is a side view of the therapeutic eye mask system of FIG. 28.

FIG. 30 shows a front view of the therapeutic eye mask system of FIG.28.

FIG. 31 shows an alternative configuration of the therapeutic eye masksystem of FIG. 30.

FIG. 32 shows a therapeutic eye mask system according to another exampleembodiment of the present invention.

FIG. 33 is a perspective view of the therapeutic eye mask system of FIG.32.

FIG. 34 is a cross-sectional view of the therapeutic eye mask system ofFIG. 33 at section line 34-34.

FIG. 35 is a perspective view of a therapeutic eye mask according toanother example embodiment of the present invention.

FIG. 36 shows the therapeutic eye mask of FIG. 35 worn by a humanpatient.

FIG. 37 is a detailed view of the back side of an eye coverage portionof the therapeutic eye mask of FIG. 35.

FIG. 38 is a cutaway view of the eye coverage portion of FIG. 37,wherein the outer cover layer is retracted.

FIG. 39 is a cutaway view of the eye coverage portion of FIG. 37,wherein the outer cover layer and intermediate layers are retracted.

FIG. 40 is a cutaway view of the eye coverage portion of FIG. 37,wherein the outer cover layer, intermediate layer, the moistureimpermeable panel, and the inner pouch are retracted.

FIG. 41 is a partial cross-section of an eye coverage portion of thetherapeutic eye mask of FIG. 35.

FIG. 42 shows a detailed cross-section of the eye coverage portion ofthe therapeutic eye mask of FIG. 35.

FIGS. 43-45 show temperature profiles of various types of phase changematerials (PCMs) depicted against an eye mask comprising onlyhydrophilic zeolite granules.

FIGS. 46A-C show a front view, a back view, and a cross-sectional viewof a strap member of a therapeutic eye mask system according to anotherexample embodiment of the present invention.

FIG. 47 is an exploded view of the strap member of FIG. 46A-C.

FIGS. 48A-C show a front view, a back view, and a cross-sectional viewof example left and right therapy pods of the therapeutic eye masksystem of FIGS. 46A-C.

FIGS. 49A-C show a front view, a back view, and a cross-sectional viewof another example left and right therapy pods of the therapeutic eyemask system of FIGS. 46A-C.

FIGS. 50A-B show a therapeutic eye mask system comprising thermochromicink printed thereon according to another example embodiment of thepresent invention.

FIGS. 51A-B show a front view and a cross-sectional view of atherapeutic system according to another example embodiment of thepresent invention.

FIG. 52 shows steps for providing prolonged heat therapy according to anexample method of use of the present invention.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

The present invention may be understood more readily by reference to thefollowing detailed description taken in connection with the accompanyingdrawing figures, which form a part of this disclosure. It is to beunderstood that this invention is not limited to the specific devices,methods, conditions or parameters described and/or shown herein, andthat the terminology used herein is for the purpose of describingparticular embodiments by way of example only and is not intended to belimiting of the claimed invention. Any and all patents and otherpublications identified in this specification are incorporated byreference as though fully set forth herein.

Also, as used in the specification including the appended claims, thesingular forms “a,” “an,” and “the” include the plural, and reference toa particular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment.

With reference now to the drawing figures, wherein like referencenumbers represent corresponding parts throughout the several views,FIGS. 1-20 show a therapeutic eye mask system according to exampleembodiments of the present invention. The therapeutic eye mask system10, shown in FIGS. 1-4, generally includes an eye mask 20 and at leastone detachable therapy pod 50. The eye mask 20 can include two separateeye coverage portions 22 connected by a nose bridge 24 and a securingstrap 26. The mask 20 is configured to be worn on the head of a humanpatient with one of the eye coverage portions 22 positioned over eacheye of the patient. In example embodiments, the securing strap 26 ispositioned around the user's head to hold the eye coverage portions 20against the eyes of the user.

In example embodiments, the mask 20 can have a monolithic uniformconstruction or may be separate pieces fastened together, for example bystitching, adhesive, fasteners or other attachment means. In exampleembodiments, the mask 20 is constructed of a lightweight and durablematerial. The mask 20 can be made of a soft and flexible material, forexample, foam or polyester. It can be constructed of perforatedthermoformed foam to improve breathability. The mask 20 can beconstructed from laminated foam or soft-flexible, open-cell foam withpolyester fabric. In particular examples, the mask 20 is constructedfrom a 2 lb./ft³, ⅜″ thick polyether polyurethane foam, flame laminatedto matte black polyester fiber interlock fabric on both sides.Alternatively, the mask 20 is constructed from polyester, rayon,spandex, silk or other natural and/or synthetic fabrics or materials.The mask material can optionally be selected to have insulative orheat-transmissive properties to affect the temperature transferred fromthe mask to the patient's eyes, ensuring safety. The material mayoptionally be washable for reuse, or alternatively can be a single-usedisposable product. In example embodiments, the mask 20 may beconstructed of a material containing nanobeads comprising anantimicrobial metal.

The mask 20 depicted in FIGS. 1-4 includes two eye coverage portions 22.The eye coverage portions 22 are designed to be independent structuressuch that each can independently conform to the respective eye region ofthe patient. The eye coverage portions 22 can each include a receiver 30for holding a detachable therapeutic pod 50. The receivers 30 areconfigured to hold the pods 50 in position over the patient's eyes whenthe mask 20 is worn. In example embodiments, the receivers 30 arepermanently-formed indents or pockets in the eye coverage portion 22.For example, the indents or pockets can be positioned on the side of themask that directly faces the eyes of the patient when worn. In use, tworemovable pods 50 are received in the mask 20, one within each of thereceivers 30. Each eye coverage portion 22 can optionally include an eyecushion 32 and an eye cover 34. The eye cushion 32 is configured tosurround the receiver 30 and provide padding on a portion of the mask 20that abuts the users face when worn. The eye cover 34 is configured tocover the outside of the eye coverage portion 22. In alternativeembodiments, the mask 20 does not include an eye cover 34 and the eyecoverage portion 22 is formed from a circular frame that is open when adetachable pod 50 is not in the receiver 30. The eye coverage portions22 can be a substantially round shape as depicted in FIGS. 1-4 or can bean oval, elliptical, polygonal, angled or another non-round shape.

The eye coverage portions 22 can be connected by a nose bridge 24 and asecuring strap 26. The nose bridge 24 can be formed from a flexibleand/or elastic material that allows the nose bridge to fit the faceshape of a variety of users. In alternate embodiments, the nose bridge24 is adjustable. In the depicted embodiments, the securing strap 26 isformed from a strap extending between the eye coverage portions 22. Thesecuring strap 26 can include an adjustment mechanism 40 that allows theuser to adjust the length of the strap. In alternate embodiments of theeye mask 100, depicted in FIGS. 5 and 6, the securing strap 126 isformed from two straps, each coupled at a first end to an eye coverageportion 122. The second end of each securing strap 126 is configured tobe removably coupled to the other securing strap. The attachmentmechanism can include snaps, ties, hook-and-loop fasteners or otherreleasable attachment mechanisms. The nose bridge 24 and securing strap26 are configured so that the eye mask 20 can be one size to fit all ormost users. Alternatively, the eye mask 10 can be produced in differentsizes. The securing strap can also include a comfort wrap (notpictured). In alternate embodiments, the mask 20 can include dualsupports to fit over the ears in place of the securing strap 26.

In other embodiments, the mask portion 220 of the therapeutic eye masksystem 200 is shaped similar to swimming goggles. The eye coverageportions 222 have a teardrop shape with the top and bottom having acurved shape and the side adjacent the nose bridge being straight so asto follow the angle of the nose. The detachable pods 250 have agenerally oval shape and are angled relative to the nose bridge 224. Thenose bridge 224 can include a padded portion 242 to provide comfort whenworn. The eye covers 234 can be perforated for breathability. Thesecuring strap 226 of the depicted embodiment includes two adjustmentmechanisms 240, one adjacent to each of the eye coverage portions 222.

The mask 20, 220 portion of the therapeutic eye mask system 10, 200 isdesigned to fit securely to the patient's eye region with an eyecoverage portion 22, 222 over each eye, the nose bridge 24, 224positioned across the patient's nose and the securing strap 26, 226extending around the back of the patient's head, as shown in FIGS. 9-11.The eye mask 20, 220 is designed such that it can be safe andcomfortable to wear while sleeping, as shown in FIG. 10. The secure fitcan also prevent air from being blown into the eye while the mask isbeing worn, for example when worn in combination with a CPAP machine. Inexample embodiments, the dual eye coverage portion design allows fullconformance within the eye socket. The design also optionally allowsheat and moist therapy to reach the sinuses to help relieve sinuspressure.

As discussed above, the eye coverage portions 22 of the mask 20 eachinclude receivers configured to releasably secure a therapy pod 50. Inexample embodiments, the pods 50 have a soft outer shell constructionthat is able to contain a fill material capable of delivering therapytreatment, for example, moist heat and cold treatments. The outer shellof the pods 50 can be formed of fabric, non-wovens or other natural orsynthetic materials, and is preferably thermally and moisturetransmissive, to allow heat and/or moisture to pass through the shell toand from the fill material. Example fill materials include hydrophiliczeolite granules or particles, and optionally silver or otherantimicrobial treatments, and/or other materials. The fill material canbe loosely contained and held within the pod 50 such that each pod willconform to the eye area of the patient when worn. Alternatively, aliquid or gel fill material can be used. The pods 50 can be designed forsingle use or can be washable and re-usable.

In example embodiments, the fill material contained within the podscomprises a synthetic porous crystalline granular aluminosilicatezeolite, for example, a hydrophilic natural or synthetic zeolite, alsoreferred to as a molecular sieve material, or other substances withsimilar properties. The fill material may further comprise other inertadditives and physical matrices without affecting the antimicrobial andhydrous efficacies of the fill. The hydrophilic zeolite granules orbeads are configured to repeatedly absorb and release moisture withoutsubstantially changing shape or form. Optionally, the pods comprise agranular fill material such as activated alumina, silica gel, bentoniteor hydrophilic zeolite or molecular sieve material. In alternateembodiments, the pods comprise capsules or packets of non-granularmaterial (e.g., gel, liquid), powder, or other materials. The pods orgranules contained in the pods optionally also contain a metallic orother antimicrobial agent, such as for example a silver, copper, copperoxide, gold, magnesium oxide, aluminum oxide, titanium dioxide, zincoxide, cobalt, nickel, zirconium, molybdenum, tin, lead and/or othermetals, metal oxides, metal ions, metal particles or nanoparticles, andalloys, mixtures or combinations thereof deposited therein. For example,silver or another metal loading of the fill may be attained by theprocess of ion-exchange. In this process, a solution containing atomicsilver or a composition of silver bathes or is passed through a bed ofthe fill granules. An ion-exchange column method may be performed inwhich an aqueous solution containing atomic silver or a composition ofsilver may be passed through a column bed of the fill granules, and theeluted solution may again be passed through the bed or may receiveadditional silver and then be again passed through the bed.

Various ion-exchange schedules as known in the art may be applied toproduce retention of the silver or other metals in the fill material ofthe pods. For example, the final content by weight of an atomic silveror silver composition, or other metals or antimicrobial agents, may beas high as twenty percent of the final loaded fill granules. In exampleembodiments, the loaded fill granules produced by ion-exchange willexhibit high retention of the silver or other metals even undersubsequent exposure to fluids and microwave irradiation. The fillgranules may comprise a blend of both metals loaded and unloaded (i.e.,not containing metal) zeolite or other substance(s) retaining silver orother metals. The presence of the atomic silver or other metalspreferably will not interfere with the useful properties of the fillgranules such as the moisture desorption and adsorption properties whichmay be desirable in the use of the eye mask or compress system. Theinherent hydrophilic nature of example forms of zeolite fill materialsprovides that substantial water content is available therein byabsorption from the atmosphere. The water so absorbed may be sufficientfor moist heat delivery applications, or may be supplemented by manuallyadded water, for providing a microwave responsive water content of theeye mask or compress system. The compositions of silver or other metalsused may include but are not limited to, metal compounds, and metalsalts such as silver chloride and silver nitrate.

The presence of the silver or other metals within the fill granulesoptionally contained in the pods of the invention providesanti-microbial properties to the therapeutic eye mask system. Theion-exchange loaded fill granules will preferably retain the silver orother metals despite microwave heating as may be required in the use ofthe eye mask or compress system. Further, the retention of the silver orother metals within the fill granules provides assured antimicrobialperformance in a reusable and potentially washable, if so desired, moistheat therapy compress. In other embodiments, the silver or other metalsare incorporated into the cover material of the pods, the eye coverageportions, and/or other portions of the eye mask system, in addition toor instead of the fill granules. Alternatively, one or more non-metalantimicrobial materials and/or medications may optionally beincorporated into the fill material, the pods, the eye coverageportions, and/or other portions of the eye mask system.

In example embodiments of the therapeutic eye mask system 300, the pods350 are push-fitted into the receivers 330 in each eye coverage portion322, as shown in FIG. 12. The pods 350 can be detachably secured withinthe receivers 330 through the use of an attachment mechanism, forexample, a hook-and-loop fastener material secured to both the pods andthe receivers, by friction fit, or otherwise. Alternatively, the pods350 are secured with a positive lock, clip, or a rigid snap. In otherembodiments of the therapeutic eye mask system 400, the pods 450 can beslid into the receivers 430 through an opening in the top of the eyecoverage portion 422, as shown in FIG. 14. The pods 50 may be round sothat they are self-orienting when attached or inserted into the mask, orcan be oval, elliptical, polygonal, angled or another non-round shape,as shown in FIG. 17. The pods can be provided in one or more differentcolors, for example, color coded based on their function. For example, apod for moist heat treatment may be red and a pod for cool treatment maybe blue. The pods 50 can also be provided in different sizes, as shownin FIG. 18. In example embodiments, the material and configuration ofthe mask form a seal against the wearer's face surrounding the eye areato prevent external airflow from drying the wearer's eyes or drying thepods or medication components positioned within the mask during use.

In use, the entire mask with the pods attached can be heated or cooledprior to use to provide therapy. The mask can be placed in the microwaveto be heated or in the freezer to be cooled. Alternatively, the podsalone can be heated or cooled detached from the mask, then placed in themask when they reach the desired temperature for treatment.

Additionally, various medicaments can be applied and used with respectto the pods. For example, one or more ophthalmic medications can beinfused or injected into the formulation in the pods. Examples ofmedicants or therapeutic materials capable of delivery using thetherapeutic device according to example forms of the invention include ajojoba formulation for treatment of the symptoms of dry eye, steroidssuch as clobetasol propionate, betamethasone dipropionate, amcinonide orloteprednol etabonate for treatments of diseases of the eyelid, such aschatazion, blepharitis or meibomian gland dysfunction. Medicants mayalso comprise a dietary or nutritional supplement composition comprisingan effective amount of omega-3 fatty acids for treatment of dry eye ormeibomianitis. Medicants may also comprise tetracycline,corticosteroids, androgens or androgen analogues. The medicant can alsocomprise a topical treatment to elevate the side effects ofchemotherapy, including eyelash loss.

In alternative embodiments, the therapeutic eye mask system 400 may becombined with a heat-transmissive pad or lid scrub or disc 452 that isapplied to the skin surface on the eyelid and around the eye, as shownin FIG. 13. In example embodiments, the pad or disc is constructed of anon-woven material and optionally a material that can be RF or thermallysealed to hold an antibacterial or other medication. The pad or disc 452can be impregnated with medication and can be effective in either amoist or dry condition. The antibacterial medication can include, forexample, liposomes and/or microspheres. The pad or disc 452 can beremovably secured to the compress for single use or multiple uses. Thepad can also be impregnated with materials to improve the aesthetics ofthe eye, like Vitamin E.

In example embodiments, the medication pad or disc 453 ismoist-heat-transmissive, and application of moist-heat activates therelease of the impregnated medication from the pad 452 onto the skinsurface of the eyelid or other tissue in or around the user's eyes. Inexample forms, the pad or disc is constructed to prevent the impregnatedmedication from passing back into the compress during application. Forexample, a one-way sheet barrier material can be placed between the pador disc and the compress to prevent any antibacterial medication fromthe disc from entering the compress.

In example embodiments, the medication pad or disc 452 can have a roundor oval disc shape with appropriate size and shape to be placed over asingle eyelid or attached to a single eye coverage portion 422. In use,two pads or discs can be used, one attached to each eye coverage portion422. A plurality of discs can be stored within a container containingantibacterial medication fluid, so as to pre-moisten the discs duringstorage. In an exemplary manner of use, two discs are removed from thecontainer and one is placed over each eye of a patient while the patientis lying down and the mask is placed over the discs so that the discsare held in between the eye and the eye coverage portion. Alternatively,the disc 452 may be attached to the detachable pod 450, such that whenthe eye mask or compress is worn, the disc rests in between the eyelidand the detachable pod. In other embodiments, the disc 452 is placed inthe receiver 430 with the detachable pod 450.

In other example embodiments, the medicated disc is used as an eyelidcleaning or treatment wipe. The medicated disc is impregnated with a dryspecialized formula that is activated by the heat and moisture from themask. The medication assists in preparing debris in the eye for removal.The disc can then be removed from the mask and used to scrub or wipe theeye area, removing the debris. The disc can be formed of a scrim ornon-woven material that accepts dry impregnation of specialized formulasor medication. Ideally, the medicated disc allows the passage ofmoisture and heat. The medicated disc can remove oil debris and pollenfrom the eyelids and enhance the moisture of the skin around the eye.The disc can also protect the mask itself from make-up or othercontaminants.

The therapeutic eye mask system 200 can also include a storage bag 260,as shown in FIGS. 19 and 20. In the depicted embodiment the mask portion220 is configured to fold at the flexible nose bridge 224 to fit withinthe storage bag 260. The securing strap 226 can be detached from themask 220 for storage, as shown in FIG. 19, or the mask 220 can be storedwith the securing strap 226 attached, as shown in FIG. 20.

FIGS. 21-24 show a therapeutic eye mask system 600 according to anotherexample embodiment of the invention. The eye mask system 600 generallyincludes a mask portion or strap 626 and one or more pods 650 that aredetachably secured to the strap. In this embodiment, the pods 650 areattached directly to the strap 626 without the need for a receiver as inprevious embodiments. The strap 626 is positioned around the user's headto hold the pods 650 in contact with the eye area of the user. The pods650 are releasably attached to the strap 626 using an attachmentmechanism such as snaps, ties, hook-and-loop fasteners or otherreleasable attachment mechanisms. The pods 650 are attached directly tothe strap 626 such that the back side of each pod directly contacts thefront of the strap. The front of each pod 650 faces away from the strap626 and is configured for contact with the eye area of the patient. Inexample embodiments, the pods 650 can be attached at a plurality ofpoints along the strap 626, as shown in FIG. 23, such that the user canadjust the pods to fit their unique face shape. The pods 650 can also beused independently of the strap 626.

The pods 650 can also include a divot, recess, depression, or other void680 configured to be positioned over the wearer's corneas when the maskis worn. As explained above, high temperatures may be unsafe for thecornea and the divot or recess 580 positioned over and around the corneacan help prevent the application of excess heat on and around thecornea, preventing conditions such as corneal warping, while allowingheat therapy to reach the eyelid and surrounding eye area.

As in previous embodiments, the pods 650 comprise an outer shell 652that surrounds and contains a fill material 654. The pod shell 652 isformed from a flexible material such as a fabric. In exampleembodiments, the pod shell 652 is formed, in whole or in part, from amaterial with antimicrobial properties. The pod shell 652 material canincorporate an antimicrobial substance, such as silver or otherantimicrobial metals. In example embodiments, silver salts or particlesare attached to the pod shell fabric. In other embodiments, silver saltsor particles are incorporated into fabric fibers such as polyesterfibers. The silver particles are encapsulated by the plastic whichprotects them during manufacturing and use of the mask. The silverimpregnated yarn is woven into the fabric of the pod shell 652. Thesilver impregnated yarn helps ensure that the antimicrobial silverparticles are distributed throughout the pod shell 652. The mask canmaintain its antimicrobial properties through repeated uses andlaundering. The antimicrobial material is configured to kill bacteria inand around the user's eye by contact. In example embodiments, theantimicrobial material will kill 99% of bacteria after 4 hours ofcontact. In example embodiments, the section of the pod shell 652 thatcontacts the user's face includes the antimicrobial fibers. In otherembodiments, the entire pod shell 652 is formed from a materialincorporating antimicrobial fibers. In example embodiments, othercomponents of the mask, such as the strap, are also formed from anantimicrobial material as described above.

The fill material 654 generally comprises a plurality of fill beads orgranules. The fill material 654 is contained by the pod shell 652 suchthat it remains within the shell and does not fall out. The fillmaterial 654 is generally able to move within the pod shell 652 suchthat the shape of the pod 650 will conform to the face of the user. Inexample embodiments, the fill beads or granules 654 can be formed from aresilient, deformable material, such as silicon. The resilient,deformable fill beads contribute to the comfort of the user.

FIGS. 25-26 show a therapeutic eye mask system 700 according to anotherexample embodiment of the invention. The mask system 700 includes atherapeutic mask similar to those described above. The mask system 700also includes a treatment sheet 752 that can be placed between the eye Eof the user and the pod 750 or eye coverage portion. The treatment sheet752 is generally impregnated with a unique therapeutic formula designedfor a specific treatment of the eye area E of a patient. In exampleembodiments, the treatment sheet 752 is heat-transmissive, such thatwhen the treatment sheet is heated or exposed to a heat source, theimpregnated medication is released from the sheet and is able to travelto the eye area of the patient. The treatment sheets can be dry whenimpregnated with medication. These treatment sheets or pads can be usedwith a dry heat source. These treatment sheets 752 do not have to bestored in an air-tight container to prevent drying out. These treatmentsheets also can be used without having to wet the sheet prior to use.

In example embodiments, the treatment sheets 752 can be aheat-transmissive pad or lid scrub or disc that is applied to the skinsurface on the eyelid and around the eye E. The pad or disc 752 can beconstructed of non-woven material and optionally a material that can beRF or thermally sealed to hold an antibacterial or other medication. Thepads or sheets 752 can be formed from any material that acceptstreatment materials and holds them in a dry state until activated bymoisture and/or heat. The pad or disc can be impregnated with medicationand can be effective in either a moist or dry condition.

In example embodiments, the medication pad or disc ismoist-heat-transmissive, and application of moist-heat source activatesthe release of the impregnated medication onto the skin surface of theeyelid or other tissue in or around the user's eyes. In example forms,the pad or disc is constructed to prevent the impregnated medicationfrom passing through the back of the disc away from the treatment area.For example, a one-way sheet barrier material can be placed between thepad or disk and the compress to prevent any antibacterial medicationfrom the disk from entering the compress.

In example embodiments, the treatment pad or disk 752 can have a roundor oval shape, as shown in FIG. 25. The treatment disk 752 is generallya size and shape to be placed on over a single eyelid. In use, two padsor disks can be used, one treats each eye. In alternate embodiments, thesheets can be shaped to cover the entire eye treatment area. A pluralityof disks can be stored within a container containing antibacterialmedication fluid, so as to pre-moisten the disks during storage. Inother embodiments, a medication can be sprayed on the treatment padsprior to use.

In an exemplary manner of use, two disks are removed from the containerand one is placed over each eye of a patient while the patient is lyingdown. The disk or sheet is exposed to a heat source, causing theimpregnated medication to be released towards the eye. Alternatively,the disk may be detachably or permanently attached to a reusable ordisposable compress delivering dry or moist heat, such that when the eyemask or compress is worn, the disk rests in between the eyelid and thedetachable pod. The pad or sheet can include a means for attaching thepad to a compress. Attachment means can include an adhesive material ora fastening device such as a hook and loop fastener. In alternateembodiments, the pad or sheet can be activated by another deviceproducing dry or moist heat, such as a humidifier, a steam or watervapor generator, a heating pad, etc.

Examples of medicants or therapeutic materials capable of delivery usingthe therapeutic device according to example forms of the inventioninclude a jojoba formulation for treatment of the symptoms of dry eye,steroids such as clobetasol propionate, betamethasone dipropionate,amcinonide or loteprednol etabonate for treatments of diseases of theeyelid, such as chatazion, blepharitis or meibomian gland dysfunction.The medicant can include honey, for example, manuka honey. The medicantor medication can include natural oils including coconut or tea treeoils for the treatment of conditions including Blepharitis. The medicantcan be an antibacterial medication including, for example, liposomesand/or microspheres. Medicants may also comprise a dietary ornutritional supplement composition comprising an effective amount ofomega-3 fatty acids for treatment of dry eye or meibomianitis. Medicantsmay also comprise tetracycline, corticosteroids, androgens or androgenanalogues. The medicant may also comprise a topical treatment to elevatethe side effects of chemotherapy, including eyelash loss. The medicantcan include menthol configured to stimulate lacrimoation via activationof cold-sensitive primary afferent neurons in the cornea. Repeated useof menthol can induce persistent increases in tear fluid volume and tearfilm stability in dry eye patients.

In further embodiments, the therapeutic device takes the form of ahygienic cleaning sheet or pad, including a heat-transmissive substrateconfigured for cleaning away makeup, debris, oils, contaminants or othermaterials from a user's eyelids, eyelashes, and surrounding tissue. Thesheet or pad may be utilized for hygienic cleansing before, duringand/or after application of heat. The substrate is optionally dry coatedwith one or more natural oils or other hygienic cleansing materials suchas for example coconut or tea tree oils, manuka or other honey, menthol,and/or vitamin E. The natural oils or other hygienic cleansing materialsoptionally provide antibacterial or antimicrobial treatment. In exampleembodiments, the natural oils or other hygienic cleansing materials aredry coated onto/into the substrate, and configured for release from thesubstrate toward and onto the eyelids and surrounding tissue or otherbody parts of a human or animal user, upon application of heat(including moist heat) to the therapeutic device and/or the targetedtissue or body part(s). The natural oils or other hygienic cleansingmaterials are preferably activated to therapeutically effective levelsby application of heat (including moist heat) at safe and comfortabletemperatures and moisture levels.

FIG. 27 shows a therapeutic eye mask or compress 800 according toanother example embodiment of the present invention. The mask 800generally includes at least one, and in the depicted embodiment twoseparate eye coverage portions 820, each configured to be positionedover the user's eyes when the mask is worn and deliver moist heattherapy. The eye coverage portions are connected by a flexible nosebridge 822 and a securing strap or head band 824, as shown in FIG. 27.In example embodiments, the nose bridge 822 and/or securing strap 824may comprise a flexible elastic material or strip, and optionally alsocomprise one or more attachment or the like, to allow attachment andoptionally also comprise one or more attachments or connection elementssuch as hook-and-loop attachment material, snaps, clips, buttons or thelike to allow attachment and optionally adjustment of the fit around theuser's head. The mask 800 is configured to be worn on the head of ahuman or animal patient with one of the eye coverage portions 820against or adjacent over the eyes of the user, as shown in FIG. 27. Inalternate embodiments, a mask or compress having a single eye coverageportion is provided, allowing the user to treat one eye at a time,leaving the other eye uncovered.

FIGS. 28-31 show a mask 900 according to another example embodiment ofthe present invention. In the depicted embodiment, each eye coverageportion 920 includes an opening, recess, depression, slit or anothervoid 980 configured to be positioned over the wearer's corneas when themask is worn. Temperatures over 39.5° Celsius may be unsafe for thecornea. The openings or voids 980 positioned over and around the corneacan help prevent the application of excess heat on and around thecornea, preventing conditions such as corneal warping, while allowingmoist heat therapy to reach the eyelid and surrounding eye area. Inexample embodiments, the cornea voids 980 are around 15 mm wide. Inexample embodiments, the voids 980 can be recessed in the eye coverageportion 920 or detachable pods or alternatively can be slits or openingsextending through the entire thickness of the eye coverage portion anddetachable pods whereby the user can see through the openings when worn.In alternate embodiments, the eye coverage portions or detachable podscan include a heat insulating material applied over one or more portionsof the eye covers configured to be positioned over the corneas when inuse. For example, an insulating shield can be attached to the centralregions of each eye cover 920 or detachable pod. The insulating shieldis configured to vault the cornea and prevent the application of excessheat on or around the corneas. This embodiment can further include anadjustable, flexible nose bridge 922. The adjustable nose bridge 922allows the user to adjust the spacing distance between eye coverageportions 920 and/or between the voids in each eye cover to accommodatevarying distances between human eyes from one individual to the next.The average pupillary distance for a human is around 57 mm to 65 mm. Inexample embodiments, the adjustable nose bridge 922 can be changed toaccommodate a distance between cornea areas ranging from about 45millimeters to about 74 millimeters. This range is sufficient toaccommodate the eye placement of the majority of adult and/or child maleand female humans. In example embodiments, one or more adjustable orexpandable straps or bands are provided between the eye covers to allowadjustment of the relative positions or spacing of the eye covers.Alternatively, the eye covers can be detachably mounted to the retentionstrap, for example with hook-and-loop fastener material, to allow forrepositioning of the eye covers on the strap to vary the spacing andposition of the eye covers.

FIGS. 32-34 show a therapeutic eye mask or compress 1000 according toanother example embodiment of the present invention. The therapeutic eyemask 1000 generally includes at least one, and in the depictedembodiment two separate eye coverage portions 1020, each configured todeliver moist heat therapy to the eye regions of the user, connected bya nose bridge 1022 and a securing strap 1024 for placement around theuser's head to hold the compress 1000 in place, as shown in FIG. 32-33.In example embodiments, the nose bridge 1022 and/or the securing strap1024 may comprise a flexible elastic material or strip, and optionallyalso comprise one or more attachment or connection elements such ashook-and-loop attachment material, snaps, clips, buttons or the like, toallow attachment and optionally adjustment of the fit around the user'shead. One or more size-adjustment connections are optionally provided toallow the user to fit the compress 1000 to their head and eye regions.The mask 1000 is configured to be worn on the head of a human or animalpatient with one of the eye coverage portions 1020 positioned over arespective eye of the patient. In example embodiments, the securingstrap 1024 is positioned around the user's head to hold the eye coverageportions 1020 against or adjacent over the eyes of the user, as shown inFIG. 32. In alternate embodiments, a mask or compress having a singleeye coverage portion is provided, allowing the user to treat one eye ata time, leaving the other eye uncovered, or a larger mask configured tocover both eyes may be provided.

Each eye coverage portion 1020 has an inner front face or applicationside 1070, configured to rest against the face of the patient (the inneror patient treatment side of the compress), and an outer back face ordistal side 1060 opposite the front face (the outer or distal side ofthe compress). In example embodiments, the inner or front face 1070 ofthe eye coverage portion 1020 has a different appearance and/or texturethan the outer or back side 1060, to allow a user to readilydifferentiate which side of the compress is the patient treatment sideto be applied over and against the patient's eye region. For example,the inner or front side 1070 may comprise a smoother or softer materialwithout coloration or printing, whereas the outer or back side 1060 maycomprise a more durable or rougher textured material having brandingtext or logos, or other coloration or indicia imprinted or otherwiseapplied thereon. Alternatively, instructional information may beimprinted or otherwise applied on one or both sides (for example, “thisside toward you” printed on the inner or front side).

In the depicted embodiment, each eye coverage portion 1020 also includesa recess or depression 1080 created by a segment of stitching, suture orother means of attachment between the inner face 1070 and the outer face1060, forming a pinched or retracted central region in each eye coverageportion. The recess 1080 is configured to be positioned over the centerof the wearer's eye to protect the wearer's corneas from excess heatand/or to provide improved comfort when the mask is worn. Temperaturesover 39.5° Celsius may be unsafe for the cornea. The recesses 1080 arepositioned over and around the cornea to provide a localized non-contactor lesser contact area to help prevent the application of excess heat onand around the cornea, preventing conditions such as corneal warping,while allowing moist heat therapy to reach the eyelid and surroundingeye area. In example embodiments, the recess or depression 1080 isformed in at least the inner or front side 1070 of the eye coverageportion(s), and optionally in both the inner side 1070 and the outerside 1060 as depicted. In example embodiments, the stitched segments1080 are about 5-15 mm wide, and preferably about 8-12 mm wide, forexample about 10 mm wide. In example embodiments, the recessed regions1080 are formed by sewing a thread through both the inner and outer facepanels 1070, 1060, or alternatively by adhesive attachment, thermalbonding, staple, clip or other attachment or coupling means. In exampleembodiments, the stitched recesses 1080 can be formed in the eyecoverage portions 1020 as depicted or in detachable pods as describedelsewhere herein.

As in previous embodiments, the eye coverage portions 1020 comprise anouter fabric shell that surrounds and contains a loose granular orparticulate fill material 1040. The shell is formed from a flexiblematerial such as a knitted or woven fabric. In example embodiments, theshell is formed, in whole or in part, from a material with antimicrobialproperties. For example, the shell material can incorporate anantimicrobial substance, such as silver or other antimicrobial metals.In example embodiments, silver salts, fibers or particles are attachedto or embedded or woven within the eye coverage shell fabric. In otherembodiments, silver salts or particles are incorporated into fabricfibers such as polyester fibers. The silver particles are optionallyencapsulated by the fiber material which protects them duringmanufacturing and use of the mask. In example embodiments a silverimpregnated yarn is woven into the fabric of the shell. The silverimpregnated yarn helps ensure that the antimicrobial silver particlesare distributed throughout the eye coverage portion shell. The mask canmaintain its antimicrobial properties through repeated uses andlaundering. The antimicrobial material may be configured to killbacteria and pathogens in and around the user's eye by contact. Inexample embodiments, the antimicrobial material will kill 99% ofbacteria after 4 hours of contact. In example embodiments, the sectionof eye coverage portion 1020 that contacts the user's face includes theantimicrobial fibers. In some embodiments, the entire eye coverageportion 1020 is formed from a material incorporating antimicrobialfibers. In particular example embodiments, the shell fabric comprises5-15% elastic fabric, 25-35% material with antimicrobial properties, and50-70% regular fiber, including but not limited to cotton, polyester,wool, silk, and flax, and/or combinations thereof. In furtherembodiments, the shell fabric is formed from about 10% elastic fabric,about 30% material with antimicrobial properties, and about 60% regularfiber. In example embodiments, the material incorporating antimicrobialproperties may comprise a PurThread® material and the elastic materialmay comprise Lyrcra®. In example embodiments, other components of themask, such as the strap, are also formed from an antimicrobial materialas described above.

The fill material 1040 generally comprises a plurality of fill beads orgranules. The fill material 1040 is contained within each eye coverageportion 1020 such that it remains within the shell and does not fallout. The fill material 1020 is generally able to flow or move within theeye coverage portions such that the shape of the coverage portion 1020will conform to the face of the user. In example embodiments, the fillbeads or granules 1020 can be formed from a resilient, deformablematerial, such as silicon. The resilient, deformable fill beadscontribute to the comfort of the user. In example embodiments, the fillmaterial 1040 contained within the eye coverage portion 1020 comprises asynthetic porous crystalline granular aluminosilicate zeolite, forexample, a hydrophilic natural or synthetic zeolite, as previouslydisclosed herein.

FIGS. 35-42 show a therapeutic eye mask or compress according to anexample embodiment of the present invention. The therapeutic eye mask1100 generally includes at least one, and in the depicted embodiment twoseparate eye coverage portions 1120, each configured to deliver moistheat therapy, connected by a nose bridge 1122 and a securing strap 1124,as shown in FIG. 35. In example embodiments, the nose bridge 1122 and/orthe securing strap 1124 may comprise a flexible elastic material orstrip, and optionally also comprise one or more attachment or connectionelements such as hook-and-loop attachment material, snaps, clips,buttons or the like, to allow attachment and optionally adjustment ofthe fit around the user's head. The mask 1100 is configured to be wornon the head of a human or animal patient with one of the eye coverageportions 1120 positioned over each eye of the patient. In exampleembodiments, the securing strap 1124 is positioned around the user'shead to hold the eye coverage portions 1120 against or adjacent over theeyes of the user, as shown in FIG. 36. In alternate embodiments, a maskor compress having a single eye coverage portion is provided, allowingthe user to treat one eye at a time, leaving the other eye uncovered.Each eye coverage portion 1120 has a front side or end 1126, configuredto rest against the face of the patient (the inner or patient treatmentside of the compress), and a back side or end 1128 opposite the frontside or end (the outer or distal side of the compress). FIG. 37 shows adetailed view of the back side 1128 of an eye coverage portion 1120. Inexample embodiments, the inner or front side 1126 of the eye coverageportion 1120 has a different appearance and/or texture than the outer orback side 1128, to allow a user to readily differentiate which side ofthe compress is the patient treatment side to be applied over thepatient's eye region. For example, the inner or front side may comprisea smoother or softer material without coloration or printing, whereasthe outer or back side may comprise a more durable or rougher texturedmaterial having branding text or logos, or other coloration or indiciaimprinted or otherwise applied thereon. Alternatively, instructionalinformation may be imprinted or otherwise applied on one or both sides(for example, “this side toward you” printed on the inner or frontside). Each eye coverage portion 1120 includes a moisture barriermaterial 1134, positioned towards the back or outer side 1128 of the eyecoverage portion, configured to prevent moisture from escaping from theback or outer side of the eye coverage portion, thereby directing moistheat therapy toward the front or inner side for application to the eyeregion of the patient (i.e., in a patient-treatment direction).

In example embodiments, the eye coverage portions 1120 are independentstructures such that each can independently conform to the respectiveeye region of the patient. For example, in the depicted embodiment asshown in greater detail in FIG. 37, the eye coverage portion 1120 has aradially curved lower or bottom profile, and a generally rectangularupper or top profile, defining a generally U-shaped configuration.Optionally, an upper attachment strip is stitched along the top edge ofthe eye coverage portion. Alternatively, the eye coverage portions canbe combined in a single panel or mask format configured to extend overboth eyes. In the depicted embodiment, each eye cover portion 1120 isformed from a series of layers or lamina. FIGS. 38-40 show successivelayers being cut away and retracted to show the series of layers orlamina, and FIG. 41 shows a cross-sectioned view of a portion of an eyecover with the successive layers or lamina indicated. For example, theeye coverage portion 1120 can include an outer cover 1130 configured tosurround the eye coverage portion 1120. The outer cover 1130 generallysurrounds both the front side 1126 and back side 1128 of the eyecoverage portion 1120, as shown in FIG. 41. The eye coverage portionalso includes an inner pouch 1136 that holds a fill material 1140, asshown in FIG. 40, configured to retain moisture and deliver moist heat.The outer cover 1130 is configured to surround and contain the innerpouch 1136. The inner pouch 1136 and outer cover 1130 are preferably atleast partially moisture permeable such that moisture and heat (moistheat) can travel from the fill material 1140 to the face of the patient.In example embodiments, the eye coverage portion 1120 also includes apanel or sheet 1134 of moisture impermeable or minimally-moisturepermeable material. The panel 1134 is positioned between the inner pouch1136 and the outer cover 1130 of the eye coverage portion 1120. Thepanel 1134 is generally positioned towards the back or outer side 1128of the eye coverage portion 1120 such that the panel is not positionedbetween the inner pouch 1136 and the face of the patient, as shown inFIG. 41. The moisture impermeable panel 1134 is configured to helpprevent the moisture released from the fill material 1140 from escapingthrough the back end 28 of the eye coverage portion 1120, and betterdirect moist heat to the subject for treatment. In example embodiments,the panel 1134 can be simply held between the outer cover 1130 and theinner pouch 1136. In other embodiments, the panel 1134 can be attachedto the outer cover 1130, the inner pouch 1136, or another part of theeye coverage portion. Example attachment means include gluing, sewing,or other fastening means. In other embodiments, the moisture barrierpanel 1134 is laminated to another layer of the eye coverage portion toform a unitary structure. The panel 1134 can be flame laminated toeliminate potential for skin contact with any irritant adhesivematerials. For example, the panel 1134 can be laminated to the outerrear surface of the inner pouch 1136 or the inner rear surface of theouter cover 1130.

In other embodiments, the eye coverage portions 1120 can include anintermediate layer 1132 in between the inner pouch 1136 and the outercover 1130, as shown in FIGS. 38 and 39. The intermediate layer 1132 isgenerally formed from a moisture permeable material. In exampleembodiments, the intermediate layer 1132 surrounds and contains theinner pouch 1136. In other embodiments, the intermediate layer 1132covers only a portion of the inner pouch 1136. In these embodiments, themoisture-barrier panel 1134 can be attached or laminated to the innerrear surface or the outer rear surface of the intermediate layer 1132.

In example embodiments, the outer cover 1130, inner pouch 1136, andintermediate layer 1132 are constructed of a lightweight, durable, andflexible material such as foam or polyester. The material is configuredto allow moist heat to reach the face of the patient but limit theamount of moisture released from the fill material. In exampleembodiments, one or more of the layers 1130/1132/1136 are formed from anopen cell thermoplastic polyurethane foam that is about 2 mm thick. Inother examples, one or more of the layers 1130/1132/1136 are constructedfrom a 2 lb/ft3 (pounds per cubic foot), ⅜″ thick polyether polyurethanefoam. The foam layers can include polyester fabric laminated onto oneside. Alternatively, one or more of the layers 1130/1132/1136 areconstructed from polyester, rayon, spandex, silk, polyethylene,neoprene, ECA, ethylene-vinyl acetate (EVA), other plastic films, and/orother natural and/or synthetic fabrics or materials having the same orsubstantially similar characteristics and capabilities. For example, oneor more of the layers 1130/1132/1136 can be formed from polyester felt.In other embodiments, one or more of the layers 1130/1132/1136 areformed from a closed cell foam. The foam can be polyurethane and/orthermoformable. The outer cover 1130 can alternatively be constructedfrom a woven material different from the inner pouch 1136 andintermediate layer 1132. The mask material can optionally be selected tohave insulative or heat-transmissive properties to affect thetemperature transferred from the mask to the patient's eyes, betterensuring safety. The material may optionally be washable for reuse, oralternatively can be a single-use disposable product. In exampleembodiments, the eye coverage portions 1120 can be constructed of amaterial containing nanobeads comprising an antimicrobial metal,medications, and/or other therapeutic material(s). Optionally, the mask1100 may be configured for use in connection with medicated ortherapeutic sheets, pods or other therapeutic accessories positioned orretained between the eye coverage portions 1120 and the subject's eyeareas. For example, the mask 1100 may be configured for supplementaldelivery and transport of medication or therapeutic material with moistheat.

The moisture barrier panel or material 1134 can be constructed of aflexible material that will limit moisture that may otherwise be lostthrough the open cell foam, e.g., a plastic material. In exampleembodiments, the panel 1134 is formed of a multilayer structure ofnylon, ethylene vinyl alcohol (EVOH), and polyethylene (PE) that isabout 4 mm thick, other plastic films, and/or other natural and/orsynthetic fabrics or materials having the same or substantially similarcharacteristics and capabilities.

In example embodiments, the fill material 1140 is loosely containedwithin the inner pouch 1136 and comprises a synthetic porous crystallinegranular aluminosilicate zeolite—e.g., a hydrophilic natural orsynthetic zeolite, also referred to as a molecular sieve material—orother substances with similar properties. In the depicted embodiment,the fill material 1140 comprises a multiplicity of individual solidbeads or granules that absorb and release moisture while generallymaintaining their individual solid shape and consistency. The fillmaterial 1140 is surrounded and contained by the inner pouch 1136 suchthat the fill material is unable to escape from the inner pouch 1136.The fill material 1140 may further comprise other inert additives andphysical matrices without affecting the antimicrobial and hydrousefficacies of the fill. The hydrophilic zeolite granules or beads areconfigured to repeatedly absorb and release moisture withoutsubstantially changing shape or form. Optionally, the fill material 1140comprise a granular material such as activated alumina, silica gel,bentonite or hydrophilic zeolite or molecular sieve material looselycontained in the pouch or other enclosure. In alternate embodiments, thefill material comprises capsules or packets of non-granular material(e.g., gel, liquid), powder, or other materials. The fill material 1140optionally also contains a metallic or other antimicrobial agent, suchas for example silver, copper, copper oxide, gold, magnesium oxide,aluminum oxide, titanium dioxide, zinc oxide, cobalt, nickel, zirconium,molybdenum, tin, lead and/or other metals; metal oxides, metal ions,metal particles or nanoparticles; and alloys, mixtures or combinationsthereof deposited therein. For example, silver or other metal loading ofthe fill material 1140 may be attained by the process of ion-exchange.In this process, a solution containing atomic silver, or a compositionof silver, bathes or is passed through a bed of the fill granules. Anion-exchange column method may be performed in which an aqueous solutioncontaining atomic silver or a composition of silver may be passedthrough a column bed of the fill granules, and the eluted solution mayagain be passed through the bed or may receive additional silver andthen be again passed through the bed.

Various ion-exchange schedules as known in the art may be applied toproduce retention of the silver or other metals in the fill material1140. For example, the final content by weight of an atomic silver orsilver composition, or other metals or antimicrobial agents, may be ashigh as twenty percent of the final loaded fill granules. In exampleembodiments, the loaded fill granules produced by ion-exchange willexhibit high retention of the silver or other metals even undersubsequent exposure to fluids and microwave irradiation. The fillgranules may comprise a blend of both metal loaded and unloaded (i.e.,not containing metal) zeolite or other substance(s) retaining silver orother metals. The presence of the atomic silver or other metalspreferably will not interfere with the useful properties of the fillgranules such as the moisture desorption, absorption, and/or adsorptionproperties which may be desirable in the use of the eye mask or compresssystem. The hydrophilic nature of example forms of zeolite fillmaterials provides that substantial water content is available thereinand readily replenished by absorption of moisture in the form of watervapor from the atmosphere or ambient surroundings at standard roomtemperatures and conditions. The water so absorbed may be sufficient formoist heat delivery applications, or may be supplemented by manuallyadded water, for providing a microwave responsive water content of theeye mask or compress system. The compositions of silver or other metalsused may include but are not limited to, metal compounds, and metalsalts such as silver chloride and silver nitrate.

The presence of silver or other metals within the fill granules, whileoptional, may provide anti-microbial properties to the therapeutic eyemask system. The ion-exchange loaded fill granules will preferablyretain the silver or other metals despite microwave heating as may berequired in the use of the eye mask or compress system. Further, theretention of the silver or other metals within the fill granulesprovides assured antimicrobial performance in a reusable and potentiallywashable, if so desired, moist heat therapy compress. In otherembodiments, silver or other metals are incorporated into the covermaterial and/or other portions of the eye mask system, in addition to orinstead of the fill granules. Alternatively, one or more non-metalantimicrobial materials and/or medications may optionally beincorporated into the fill material 1140, the eye coverage portions1120, and/or other portions of the eye mask system.

The present invention also includes a method of providing moist heattherapy to a body part of a human or animal subject. In example forms,the method includes providing a therapeutic device comprising a firstside, a second side, and a hydrophilic fill material contained betweenthe first and second sides; wherein the first side at least partiallycomprises a moisture-transmissive material allowing passage of moisturetherethrough for absorption and release into and from the fill material,and the second side at least partially comprises a moisture-impermeablematerial substantially preventing passage of moisture therethrough. Infurther example embodiments, the body part of the human or animalsubject is an eye. In further example embodiments, the method alsoincludes exposing the therapeutic device to a moisture source, such asfor example, water vapor in ambient air surrounding the therapeuticdevice to allow absorption of moisture into the hydrophilic fillmaterial. In further example embodiments, the method further includesexposing the therapeutic device to a heat source, such as for example, amicrowave oven or other heating device to allow transfer of heat intothe fill material. In further example embodiments, the method furtherincludes directing the application of the first side of the therapeuticdevice into contact with the body part to provide transmission of moistheat in a first direction from the hydrophilic fill material through themoisture-transmissive material to the body part, and to substantiallyprevent transmission of moist heat in an opposed second direction fromthe hydrophilic fill material through the moisture-impermeable materialaway from the body part. In further example embodiments, the methodfurther includes applying the first side of the therapeutic device intocontact with the body part to provide transmission of moist heat in afirst direction from the hydrophilic fill material through themoisture-transmissive material to the body part, and to substantiallyprevent transmission of moist heat in an opposed second direction fromthe hydrophilic fill material through the moisture-impermeable materialaway from the body part.

According to additional example embodiments of the present invention,one or more additional materials can be incorporated into the fillmaterial (e.g., heat transfer medium), the pods, eye coverage portions,and/or other portions of the eye mask systems as described herein. Inexample embodiments, one or more additional materials such as a phasechange material (PCM) can be blended or incorporated with one or more ofthe fill materials as described above so as to provide a more controlledand/or longer duration heat transfer medium. According to exampleembodiments, the heat transfer medium is programmed or formulated so asto provide target performance characteristics such as preventing thetemperature thereof from exceeding an upper target temperature or forexample, prolonging the release of heat therefrom such that the heattransfer medium generally remains at a substantially constanttherapeutic target temperature for a desired amount of time.

For example, according to one example embodiment, the heat transfermedium is configured to not exceed an upper target or thresholdtemperature of about 130° F. (even if the heating thereofunintentionally exceeds a prescribed heating duration) and to maintain atherapeutic target temperature of about 114° F. for at least about 12minutes. According to example embodiments, the heat transfer medium istypically heated for about 20-30 seconds in a microwave oven (typical1000-1200 watt microwave oven) such that the heat transfer mediumgenerally reaches a temperature at or below (and preferably notexceeding) 130° F., and thereafter the heat transfer medium generallyreleases the heat therefrom gradually over a sustained period of timewhile maintaining a substantially constant therapeutic deliverytemperature for at least between about 8-15 minutes. According toexample embodiments, the substantially constant temperature of the heattransfer medium is generally between about 90° F.-130° F. and in furtherexamples between about 110° F.-120° F., for example about 114° F.according to particular example embodiments.

For example, even if the heat transfer medium is heated in the microwaveoven for an extended period of time (e.g., 1-5 minutes or more), thetemperature of the heat transfer medium preferably remains at or belowabout 130° F. Thus, as the heat transfer medium is intended to providemoist heat or cold therapy, in example embodiments the heat transfermedium is incapable in a normal intended manner of use of having atemperature that could harm or injure a user or patient receiving thetherapy. Preferably, in this case the heat transfer medium is formulatedto comprise a safety mechanism such that even unintentional actions orinitial heating of the heat transfer material exceeding the prescribedduration would prevent excessive heat absorption causing the heattransfer material to attain a temperature exceeding about 130° F.

According to example embodiments, the heat transfer medium comprises amixture, combination or blend of hydrophilic zeolite granules orparticles and at least one phase change material (PCM). In other exampleembodiments, one or more additional materials can be combined orsubstituted such as a liquid or gel fill material (e.g., silica gel).According to example embodiments of the present invention and asdescribed above, the hydrophilic zeolite granules or particles areconfigured to repeatedly absorb and release moisture withoutsubstantially changing shape or form. Optionally, the heat transfermedium can comprise a granular fill material such as activated alumina,silica gel, bentonite or hydrophilic zeolite or molecular sievematerial. According to preferred example embodiments, at least one ofthe materials of the heat transfer medium is configured to absorb andrelease moisture, for example, to provide for moist heat or coldtherapy. Accordingly, it is preferred that at least one of the materialsof the heat transfer medium generates moist heat or moist coolingdepending on the process by which the heat transfer medium is activated(e.g., heated in microwave or warm or boiling water; cooled in coldwater or freezer, etc.). In alternate embodiments, the fill material maycomprise only phase change material(s); or alternatively can comprise amixture, combination or blend of phase change material(s), hydrophiliczeolite granules, and/or other thermally responsive or inertmaterial(s).

In example embodiments, the PCM comprises paraffin and can beincorporated into various delivery vehicles such as molded discs, beads,shredded discs, etc. In one example embodiment, the PCM may be siliconecomposites such as, for example, nextek43D™ or nextek6D™ in siliconewith 33 wt. % loading. The nextek43D™ silicone composites may be used tofill the internal capacity or volume of the mask, eye coverage portionsand/or pods. Alternatively, the silicone composite may be used to fillthe internal volume only partially, with or without other fillmaterials. In another example embodiment, the PCM may be high densitypolyurethane (HDPU) foam composite, such as for example nextek43D™ with66 wt. % loading and making up to 100% of internal volume of the mask,eye coverage portions and/or pods. In still another example embodiment,the PCM may be microencapsulated PCM beads comprising, for example,nextek43D™ macros. The microencapsulated PCM beads may be used toreplace up to 100 wt. %, or preferably about 25 wt. %, of the internalvolume of the mask, eye coverage portions and/or pods. In yet anotherexample embodiment, the PCM may be provided as a gel pouch comprising,for example, 6° C. nutek PCM gel which remains flexible whenfrozen/conditioned and available for use between about −10° C.-43° C.Optionally, the PCM may take on other forms such as microencapsulatedPCM beads, liquid PCM pouch, PCM dry powder, PCM wet cake, PCM slurry,etc.

TABLE 1 Typical properties of microtek PCM 37 Appearance Above meltpoint: liquid, colorless Below freeze point: solid, opaque Form BulkType Paraffin PCM Content 100% Melting Point 37° C. (98.6° F.) Heat ofFusion 210-220 J/g Density 0.79 g/ml Thermal Cycling Multiple

TABLE 2 Typical properties of microtek PCM 43 Appearance Above meltpoint: liquid, colorless Below freeze point: solid, opaque Form BulkType Paraffin PCM Content 100% Melting Point 43° C. (109.4° F.) Heat ofFusion 235-245 J/g Density 0.79 g/ml Thermal Cycling Multiple

TABLE 3 Typical properties of microtek PCM 58 Appearance Above meltpoint: liquid, colorless Below freeze point: solid, opaque Form BulkType Paraffin PCM Content 100% Melting Point 58° C. (136.4° F.) Heat ofFusion 160-180 J/g Density 0.82 g/ml Thermal Cycling Multiple

TABLE 4 Typical properties of nextek ™ 6D Appearance White to slightlyoff-white color Form Dry powder (≥97% solids) Particle Size (mean) 15-30micron Melting Point 6° C. (42.8° F.) Heat of Fusion ≥170 J/gTemperature Stability Extremely stable-less than 1% leakage when heatedto 250° C. Thermal Cycling Multiple

Tables 1-4 show specific details regarding several PCM formulations thatwere used for testing with the present invention (as will be describedin greater detail below). According to example embodiments, paraffinpreferably absorbs heat at a constant temperature (e.g., latent heat offusion) until it liquefies, for example, which is at the heat saturationpoint.

As depicted in FIGS. 43 and 44, temperature profiles of the varioustypes of PCMs are depicted against an eye mask comprising onlyhydrophilic zeolite granules. In example embodiments, each temperatureprofile depicts the temperature of the material against a time span ofabout 30 minutes, for example, where each material was individuallyheated in a microwave for 30 seconds. In example embodiments, the PCMswere incorporated into separate eye masks in a similar fashion as theeye mask comprising only hydrophilic zeolite granules. As shown, the eyemask comprising only hydrophilic zeolite granules absorb a substantialamount of heat during the 30 seconds of heating and exceed well beyondthe upper target temperature (for about 10 minutes) before falling belowthe 130° F. upper target temperature. However, both the silicone PCMcomposite and high density PU foam PCM composite both remain at atemperature below the upper target temperature and comprise a gradualand sustained temperature curve. Thus, as depicted, the temperature ofthe hydrophilic zeolite granules drop about 75 degrees over a 30 minutetime span (e.g., steep decaying temperature curve) and the PCMs drop intemperature about 35 degrees over the same 30 minute time span (e.g.,sustained temperature curve). And as depicted in FIG. 45, themacro-encapsulated PCM beads comprise a steep temperature curve that isgenerally similar to the temperature curve of the hydrophilic zeolitegranules.

As shown in FIGS. 43-45, it took about 10 minutes for the standard maskwithout PCM (e.g., comprising hydrophilic zeolite granules) to be usable(e.g., at or below the upper target temperature of 130° F.), whereasboth masks comprising PCM were usable instantly. In example embodiments,the standard mask without PCM spent 12 minutes between 130° F.-100° F.,the mask with silicone—PCM spent 18 minutes between 130° F.-100° F., themask with PU-PCM spent 6 minutes between 130° F.-100° F., and the maskwith macro-encapsulated PCM spent 21 minutes between 130° F.-100° F. Inexample embodiments, the final temperature of the mask without PCM was92° F., the final temperature of the mask with silicone-PCM was 93° F.,the final temperature of the mask with PU-PCM was 89° F., and the finaltemperature of the mask with macro-encapsulated PCM was 100° F. Andafter 10 minutes of the mask being at or below the upper targettemperature, the mask without PCM was 105° F., the mask withsilicone-PCM was 110° F., the mask with PU-PCM was 97° F., and the maskwith macro-encapsulated PCM was 107° F.

TABLE 5 Temperature Data: 6 g Disk Microwave Time: 30 seconds 1 Minute 2Minutes 3 Minutes 4 Minutes PCM Type Initial 5 min Initial 5 min Initial5 min Initial 5 min Initial 5 min nextek37 ™ 86° F. 85° F. 94° F. 89° F.108° F. 85° F. 178° F.  87° F. — — (99° F.) Nextek43 ™ 79° F. 76° F. 83°F. 79° F. 106° F. 95° F. 128° F.  98° F. 133° F. 111° F. (110° F.)Nextek58 ™ 77° F. 72° F. 81° F. 75° F. 101° F. 93° F. 117° F. 102° F.123° F. 111° F. (135° F.)

TABLE 6 Temperature Data: 20 g Disk Microwave Time: 30 seconds 1 Minute2 Minutes 3 Minutes 4 Minutes PCM Type Initial 5 min Initial 5 minInitial 5 min Initial 5 min Initial 5 min nextek37 ™ 85° F. 83° F. 99°F. 87° F. 104° F. 96° F. 116° F. 100° F. 146° F. 102° F. (99° F.)Nextek43 ™ 81° F. 80° F. 95° F. 84° F.  98° F. 92° F. 115° F. 100° F.130° F. 106° F. (110° F.) Nextek58 ™ 80° F. 75° F. 94° F. 82° F.  96° F.91° F.  11′° F. 100° F. 125° F. 108° F. (135° F.)

According to another example embodiment, additional testing wasconducted on a plurality of PCMs of various melting point temperatures.According to example embodiments, a comparison is depicted in Tables 5and 6 whereby Microtek's nextek37™ PCM (melting point of 98.6° F.),Microtek's nextek43™ PCM (melting point of 109.4° F.), and Microtek'snextek58™ PCM (melting point of 136.4° F.) are separately heated forvarious time spans (30 seconds, 1 minute, 2 minutes, 3 minutes, and 4minutes) and the initial temperatures and temperatures after 5 minutesare logged for comparison. This testing is conducted for samplescomprised of a 6 g disk (see FIG. 56) and a 20 g disk (see FIG. 57). Asdetermined after testing and comparing the resulting temperatures, at 30seconds of microwave time the heat is predominantly coming from themoist heat technology (e.g., hydrophilic zeolite granules). The highmelt point PCM decreases initial temperature but “gives back” less heat,and the lower melt point PCM has a higher initial temperature but willprovide more heat back during use.

Preferably, a combination of the moist heat technology (e.g.,hydrophilic zeolite granules, silica gel, etc.) and at least one PCM iscapable of preventing the temperature thereof from spiking above 130° F.even with extended microwave use, while allowing the mask to provideheating at or around an ideal specified temperature (˜114° F.) for aspecific amount of time (8-12 minutes). According to one exampleembodiment, the heat transfer medium can comprise a combination ofMicrotek's nextek43™ PCM (melting point of 109.4° F.) and moist heattechnology such as hydrophilic zeolite materials. According to anotherexample embodiment, the heat transfer medium can comprise a blend ofMicrotek's nextek37™ PCM (melting point of 98.6° F.), Microtek'snextek58™ PCM (melting point of 136.4° F.) and the moist heattechnology. According to some example embodiments, the total percentloading of the PCM is lowered when using Microtek's nextek43™ PCM(melting point of 109.4° F.) in combination with the moist heattechnology, or for example, a blend of Microtek's nextek37™ PCM (meltingpoint of 98.6° F.) and Microtek's nextek58™ PCM (melting point of 136.4°F.) can be combined with the moist heat technology in any desired ratio.Indeed, the moist heat technology, whether hydrophilic zeolite, silicagel, bentonite, etc. can be combined with one or more PCMs in anydesired ratio, for example, such that the desirable performance targets(e.g., heating at an ideal temperature of about 114° F. for a specificamount of time 8-12 minutes) are met. In the case of an eye maskcomprising one or more of the above-described heat transfer mediums,preferably enough PCM is present so as to create significant heattransfer to hold the user's eyelid at 114° F. for about 8-12 minutes.

Optionally, according to another example embodiment, the heat transfermedium can comprise a blend of hydrophilic zeolite, PCM and silica gel.As similarly described above, a metallic or other antimicrobial agent,such as for example a silver, copper, copper oxide, gold, magnesiumoxide, aluminum oxide, titanium dioxide, zinc oxide, cobalt, nickel,zirconium, molybdenum, tin, lead and/or other metals, metal oxides,metal ions, metal particles or nanoparticles, and alloys, mixtures orcombinations thereof may be incorporated with the heat transfer medium.For example, silver or another metal loading of one or more constituentsof the heat transfer medium may be attained by the process ofion-exchange.

FIGS. 46-49 show an eye mask 1200 according to another exampleembodiment of the present invention. In example embodiments, the eyemask 1200 comprises a generally integral strap member 1202 comprisingtwo eye coverage portions 1204, a nose bridge 1206 and securing ends1208, 1210 to be wrapped around a user's head and fastened together, forexample, with hook and loop material, snaps, couplings or other desiredfasteners. Optionally, the integral strap member 1202 forms a completeloop comprising at least some elasticity so as to accommodate user's ofvarious head sizes. In example embodiments, at least one therapy pod1220, 1240 can be removably secured to one or both of the eye coverageportions 1204 of the strap member 1202.

In example embodiments, the eye mask 1200 can be constructed from aplurality of materials such as polyester airmesh, polyester brushedtricot fleece lining, polyester batting material, polyester knit tapeand hook and loop material. In example embodiments, the eye mask 1200comprises a binding or closing seam 1212, an exterior layer 1214, anintermediate layer 1216, and an interior layer 1218, as shown in FIGS.46 and 47. According to the depicted embodiment, binding 1212 is a 20 mmpolyester knit tape. The exterior layer 1214 is constructed frompolyester airmesh and comprises a portion of 38 mm loop material 1214 a.The intermediate layer 1216 is constructed from polyester battingmaterial. The interior layer 1218 comprises one or more sections ofpolyester airmesh 1218 a, polyester brushed tricot fleece lining 1218 b,and 38 mm hook 1218 c adapted to engage loop material 1214 a.

As depicted in FIGS. 48A-C, a first therapy pod 1220 comprises a softouter shell construction 1226 that is able to contain the heat transfermedium within a containment area 1224 (e.g., fill material) and iscapable of delivering therapy treatment, for example, moist heat andcold treatments. The outer shell 1226 of the pods 1220 can be formed offabric, non-wovens or other natural or synthetic materials, and ispreferably thermally and moisture transmissive, to allow heat and/ormoisture to pass through the shell to and from the fill material.Example fill materials include hydrophilic zeolite granules orparticles, and optionally silver or other antimicrobial treatments,silica gel, one or more PCMs, and/or other materials. The fill materialcan be loosely contained and held within the containment area 1224 ofthe pod 1220 such that each pod will conform to the eye area of thepatient when worn. Alternatively, a liquid or gel fill material can beused. According to another example embodiment, a silicone disc or highdensity foam panel or other flexible pouch or pack (all of which cancomprise PCM) can be incorporated within the pod 1220. The pods 1220 canbe designed for single use or can be washable and re-usable. In exampleembodiments, a rear side of each pod 1220 comprises a fastener 1222 forremovable attachment to the eye coverage portions 1204 of the strap1202. In example embodiments, the fastener 1222 comprises hook materialand loop material is secured to the eye coverage portions so as toprovide removable engagement therebetween.

As depicted in FIGS. 49A-C, a second therapy pod 1240 comprises a softouter shell construction 1246 that is able to contain the heat transfermedium within a containment area 1244 (e.g., fill material) and iscapable of delivering therapy treatment, for example, moist heat andcold treatments. The outer shell 1246 of the pods 1240 can be formed offabric, non-wovens or other natural or synthetic materials, and ispreferably thermally and moisture transmissive, to allow heat and/ormoisture to pass through the shell to and from the fill material.Example fill materials include hydrophilic zeolite granules orparticles, and optionally silver or other antimicrobial treatments,silica gel, one or more PCMs, and/or other materials. The fill materialcan be loosely contained and held within the containment area 1244 ofthe pod 1240 such that each pod 1240 will conform to the eye area of thepatient when worn. Alternatively, a liquid or gel fill material can beused. According to another example embodiment, a silicone disc or highdensity foam panel or other flexible pouch or pack (all of which cancomprise PCM) can be incorporated within the pod 1240. The pods 1240 canbe designed for single use or can be washable and re-usable. In exampleembodiments, a rear side of each pod 1240 comprises a fastener 1242 forremovable attachment to the eye coverage portions 1204 of the strap1202. In example embodiments, the fastener 1242 comprises hook materialand loop material is secured to the eye coverage portions so as toprovide removable engagement therebetween. In example embodiments, thepods 1240 comprise an outer raised rim 1248 so as to provide a divot,recess, depression, or other void 1243, which is configured to bepositioned over the wearer's corneas when the mask is worn. As explainedabove, high temperatures may be unsafe for the cornea and the divot orrecess 1243 positioned over and around the cornea can help prevent theapplication of excess heat on and around the cornea, preventingconditions such as corneal warping, while allowing heat therapy to reachthe eyelid and surrounding eye area.

In example embodiments, the eye masks and heat transfer mediums/fillmaterials as described herein are preferably beneficial in treatingMeibomian gland dysfunction (MGD), Dry Eye and/or otherophthalmic-related problems. According to one example embodiment, theeye mask can be provided in a kit form for use in a doctor's office forgland expression. The entire kit (or pods thereof) would be microwavedand applied for up to fifteen minutes and be followed by a manualexpression of the glands. According to one example embodiment, allelements of the mask are disposable. In other example embodiments, thecomponents (or at least one component thereof) can be reusable by thedoctor, or for example, at least one of the components could be kept bythe patient for home use. For example, at least the eye mask strap andpods could be reused multiple times. According to other exampleembodiments, the eye mask is not in a kit form, but rather assembledtogether by the doctor. In other example embodiments, the doctor can buythe eye mask components in mass quantity and assemble into kits to beused and taken home by the patient. According to another exampleembodiment, an eye mask kit comprising the strap and at least one ormore pods could be available for purchase at a retail store. In someexample embodiments, multiple versions of the pods can be created toprovide various therapy, for example, moist heat, moist cold, moist heatand cold, disposable moist heat and/or cold, etc.

Furthermore, additional therapeutic treatments to various other bodyparts is within the scope of the present invention, for example, whereinone or more of the above-described heat transfer mediums/fill materialscan be incorporated with various other pads, compresses, straps,harnesses, braces, supports, etc. As such, additional therapy devices orcompresses, for example, for treating other portions of a user's body(e.g., neck, back, shoulder, limb, etc.) can comprise any desired fillmaterial, for example, with or without one or more PCMs such that moistheat or cold therapy can be applied at a substantially constanttemperature for a prolonged amount of time.

FIGS. 50A-B shows an eye mask 1300 according to another exampleembodiment of the present invention. As depicted, one or more of the eyemasks, pods, or other materials or containers (e.g., containing the heattransfer medium/fill materials) as described herein can comprisethermochromic ink printed thereon. As depicted in FIG. 50A, a checkmark1302 is visible and indicates that the temperature of the unit is safefor application to the face of the user. Preferably, the thermochromicink comprises a customizable temperature range with a 1° C. accuracy.The thermochromic ink can be formulated for screen printing, UV andflexographic applications. When the temperature of the unit has exceededthe recommended application temperature, checkmark 1302 disappears, asshown in FIG. 50B. In alternate example embodiments, one or morethermally responsive indicators of various format may be applied to athermal therapy compress or other treatment device to indicate atemperature that is either within a specified range, or outside of aspecified range (for example an indicator stating “TOO HOT/COLD—DO NOTUSE” or the like when outside of a specified temperature range, and/or“SAFE TEMPERATURE FOR USE” or the like when within a specifiedtemperature range), for example by printing in thermochromic ink orother thermally responsive mode of application. Alternatively, or inaddition, thermally responsive color indicators (e.g., green for use,red for do not use) may be applied.

In further example embodiments, with reference to FIGS. 51A-B, a thermaltherapy compress 1400 incorporating one or more phase change materialsis provided and configured for application to other body parts (back,neck, eye, head, arm, leg, torso, foot, ankle, knee, hip, shoulder,elbow, wrist, hand, or other body part) of a human or animal treatmentsubject. For example, compress 1400 may comprise one or more pockets orchambers 1430 containing fill material 1440 including phase changematerial(s), for example in a shape, size and configuration adapted tofit a specified body part. The compress may include one or more straps,bands, couplings, or other attachment portion(s) 1460, optionallyincluding fastening means such as hook-and-loop material, snaps,buttons, hooks or the like for retaining the compress in place on thebody part.

According to another example embodiment the present invention relates toa cold therapy product. According to example embodiments, the coldtherapy product comprises one or more pods comprising at least one heattransfer material.

According to example embodiments, the heat transfer material comprises atype of hydrophilic silica gel, which has been “loaded” with 40-90% byweight water (e.g., water being the PCM).

According to example embodiments, the cold pod comprises an outermoisture barrier material (low MVTR—moisture vapor transmission rate)such as a PVC or Urethane material, which is shaped as desired andfilled with the water loaded silica gel. The pod is then closed with thesame barrier material as the pod and heat sealed. According to exampleembodiments, the moisture barrier material prevents the desorption ofwater from the silica gel. For example, in the case that water wasdesorbed from the silica gel, the effectiveness of the cold pod woulddecrease over time. Accordingly, the cold pod preferably comprises amoisture barrier material so as to prevent the water loaded silica gelfrom becoming less hydrated. According to some example embodiments,certain other barrier films, such as polyethylene, have a higher rate ofmoisture vapor transmission, and may not be suitable for thisapplication. In some examples, the cold pod material comprisespolyethylene. In other embodiments, the cold pod material does notcomprise polyethylene.

According to example embodiments, the silica gel particles, althoughfilled with water, remain free flowing, even when frozen orrefrigerated, thereby allowing for better conformance of the pod to theshape of the eye orbit, and thus improved conductive heat transfer fromthe skin of the eye orbit to the cold pod. Said another way, thewater-filled silica gel preferably at least partially remains in aliquid state, even when exposed to freezing temperatures, for examplewhich preferably allows for at least of the majority, if not theentirety, of the cold pod to flexibly contact the user's face, eyeand/or other body part thereof such that a maximum amount of heattransfer is obtainable, for example, by contact of the cold pod with thedesired body part of the user. According to example embodiments of thepresent invention, silica gel particles sized between about 0.5-3millimeters are preferably saturated with water and used together as theheat transfer material. According to example embodiments, smaller silicagel particles (e.g., about 0.005 to about 0.025 micron) are undesiredfor example as they are extremely small and very difficult to handle andpackage.

According to another example embodiment, the invention relates to amethod of providing prolonged heat therapy 1500, or for example,prolonged moist heat therapy to a body part of a human or animaltreatment subject, shown schematically in example form by FIG. 52.According to example embodiments, the method comprises providing a firstmaterial comprising hydrophilic zeolite at 1502; providing a secondmaterial comprising a phase change material (PCM) at 1504; combining thefirst and second materials together to form a blend or mixture at 1506;containing or packaging the blend or mixture of first and secondmaterials within a package (or pod) at 1508; and applying heat energy tothe package at 1510. In example embodiments, the first material is muchmore responsive and absorbent to the applied heat energy compared to thesecond material, and thus, the method further comprises absorbing asubstantial amount of the applied heat within the first material at1512. After heat energy is applied to the package and substantiallyabsorbed by the first material, the method further includes that theheat energy that is absorbed by the first material is transferred (byconduction, convection and radiation) from the first material to thesecond material where it is initially stored at 1514. The compress isthen applied in contact with the body part to be treated, forapplication of thermal therapy to the body part. Thereafter, the methodfurther includes that the heat energy is then released from the secondmaterial to provide thermal therapy to the treated body part over anextended amount of time at a substantially constant temperature at 1516.According to one example embodiment, the package is heated by microwaveenergy and configured not to exceed a temperature of about 130° F. afterbetween about 20 seconds-4 minutes of heating, and for example, isconfigured to maintain a temperature of about 114° F. for between about8-12 minutes. According to one preferred embodiment, the packagecomprising the first and second materials is incorporated with the eyemasks/compresses as described above such that an inner eyelidtemperature after a duration of 12 minutes is about 104° F.

According to example embodiments, the second material (e.g., PCM) cancomprise one specific phase change or melting point temperature, or forexample, the second material can comprise a mixture or blend of aplurality of PCMs with two or more different melting point temperatures.According to one example embodiment, the second material comprisesMicrotek's nextek43™ PCMs (melting point of 109.4° F.). According toanother example embodiment, the second material comprises a blend ormixture of Microtek's nextek37™ PCMs (melting point of 98.6° F.) andMicrotek's nextek58™ PCMs (melting point of 136.4° F.). According toexample embodiments, where the second material comprises a blend ormixture of two PCMs of different melting points, the ratio of the blendor mixture can be chosen as desired. According to one exampleembodiment, the blend comprises equal amounts of each of the twodifferent PCMs. According to another example embodiment, the blendcomprises unequal amounts of the two different PCMs. According to otherexample embodiments, the second material can comprise any desired PCMwith a single melting point, or for example, any desired blend ormixture of two or more PCMs with various melting points and with equalor unequal ratios. Furthermore, as described above, at step 1506 of themethod 1500, the first and second materials may not be blended together,for example, in the case where the second material (PCM) is in the formof a disc, panel and/or pouch. As such, step 1506 may comprise simplycombining the first and second materials together, for example, whereinthe combination thereof may not be entirely homogenous.

Accordingly, as described above and according to some exampleembodiments, it is the moisture-loaded zeolite particles that aremicrowave responsive (e.g., the PCM materials themselves are notstrongly microwave responsive). Further, as described above, as thezeolite particles heat, they in turn transfer heat to the one or morePCM materials. Thus, the zeolite is the primary microwave responsivematerial and moisture vapor source for moist heat therapy. The PCM isthe heat storage material and moderator of heat release and temperaturestabilization.

While the invention has been described with reference to preferred andexample embodiments, it will be understood by those skilled in the artthat a variety of modifications, additions and deletions are within thescope of the invention, as defined by the following claims.

What is claimed is:
 1. An eye compress configured to deliver moist heattherapy to at least one eye of a patient, the eye compress comprising:at least one eye coverage portion having a front side and an oppositeback side, wherein the front side is configured for contact with thepatient's body when the eye compress is worn; and at least one securingstrap affixed to the at least one eye coverage portion; wherein the atleast one eye coverage portion at least partially comprises amoisture-permeable antimicrobial material and a fill material enclosedwithin the moisture-permeable antimicrobial material, whereby the fillmaterial is configured to absorb and release moisture through themoisture-permeable antimicrobial material and deliver moist heat therapyto the eye area of the patient.
 2. The eye compress of claim 1,comprising two independent eye coverage portions and a flexible nosebridge coupled between the two eye coverage portions.
 3. The eyecompress of claim 1, wherein the fill material comprises a hydrophiliczeolite.
 4. The eye compress of claim 3, wherein the hydrophilic zeolitefill material comprises granules loosely contained within themoisture-permeable antimicrobial material.
 5. The eye compress of claim1, wherein the fill material comprises a phase change material.
 6. Theeye compress of claim 6, wherein the phase change material comprisesparaffin.
 7. The eye compress of claim 1, wherein the fill materialcomprises a blend of two or more phase change materials.
 8. The eyecompress of claim 1, wherein the fill material comprises a hydrophiliczeolite and at least one phase change material.
 9. An eye compress fordelivery of moist heat to a patient, the eye compress comprising: astrap comprising two eye coverage portions, a nose bridge extendingbetween the eye coverage portions and strap extensions oppositelyextending from the eye coverage portions; and at least one enclosurecontaining a fill material capable of absorbing and releasing moist heatfor therapeutic delivery to the patient, the enclosure having a firstside and an opposite second side, with the fill material disposedbetween the first side and the second side, wherein the first side isconfigured for application to a body portion of the patient and thesecond side is configured for removable engagement with at least one ofthe eye coverage portions.
 10. The eye compress of claim 9, wherein thefill material comprises a hydrophilic zeolite.
 11. The eye compress ofclaim 10, wherein the hydrophilic zeolite fill material comprisesgranules loosely contained within the enclosure.
 12. The eye compress ofclaim 9, wherein the fill material comprises at least one phase changematerial.
 13. The eye compress of claim 12, wherein the at least onephase change material comprises paraffin.
 14. The eye compress of claim12, wherein the phase change material comprises microencapsulated beads.15. The eye compress of claim 12, wherein the phase change materialcomprises macro-encapsulated beads.
 16. The eye compress of claim 12,wherein the phase change material comprises silicone composite.
 17. Theeye compress of claim 12, wherein the phase change material comprises agel pack.
 18. The eye compress of claim 12, wherein the phase changematerial comprises high density polyurethane foam.
 19. The eye compressof claim 9, wherein the fill material is configured for heating within amicrowave to a temperature not exceeding 130° F., and wherein the fillmaterial provides a substantially constant temperature of about 114° F.for between 8-12 minutes thereafter.
 20. A method of providing prolongedmoist heat therapy comprising: providing a first material comprisinghydrophilic zeolite; providing a second material comprising a phasechange material; combining the first and second materials together toform a bled or mixture; containing or packaging the blend or mixture offirst and second materials within a package; and applying heat energy tothe package.
 21. The method of providing prolonged moist heat therapy ofclaim 20, further comprising absorbing a substantial amount of theapplied heat within the first material.
 22. The method of providingprolonged moist heat therapy of claim 20, further comprisingtransferring the heat energy that is absorbed by the first material tothe second material.
 23. The method of providing prolonged moist heattherapy of claim 20, further comprising applying the package to atreated body part of a human or animal subject.
 24. The method ofproviding prolonged moist heat therapy of claim 20, further comprisingreleasing the heat energy from the second material over an extendedamount of time at a substantially constant temperature.
 25. A thermaltherapeutic compress for providing thermal (hot or cold) therapy to atreated body part of a human or animal subject, the compress containingat least one phase change material.
 26. The thermal therapeutic compressof claim 25, wherein the compress further comprises a moist heatdelivery material.
 27. The thermal therapeutic compress of claim 25,wherein the treated body part comprises the back, neck, eye, head, arm,leg, torso, foot, ankle, knee, hip, shoulder, elbow, wrist, hand, orother body part of the human or animal subject.
 28. A cold therapydevice comprising: a container or reservoir comprising an outer moisturebarrier material comprising a moisture vapor transmission rate; silicagel particles sized between about 0.5-3 millimeters; and a quantity ofwater.
 29. The cold therapy device of claim 28, wherein the heattransfer material comprises a type of hydrophilic silica gel, which hasbeen “loaded” with 40-90% by weight water.
 30. A compress fortherapeutic treatment of a body part, the compress comprising: an outershell having an external contact surface for contact with the body part,and defining at least one internal enclosure within the flexible shell;a first fill material contained within the at least one enclosure, thefirst fill material comprising a hydrophilic material; and a second fillmaterial contained within the at least one enclosure, the second fillmaterial comprising a phase change material.
 31. The compress of claim30, wherein the first fill material is microwave responsive.
 32. Thecompress of claim 30, wherein the first fill material comprises ahydrophilic zeolite.
 33. The compress of claim 30, wherein the phasechange material has a phase change temperature of between about 98° F.to about 136° F.
 34. The compress of claim 30, wherein the phase changematerial comprises paraffin.
 35. The compress of claim 30, wherein thephase change material comprises microencapsulated beads.
 36. Thecompress of claim 30, wherein the phase change material comprisesmacro-encapsulated beads.
 37. The compress of claim 30, wherein thephase change material comprises silicone composite.
 38. The compress ofclaim 30, wherein the phase change material comprises a gel.
 39. Thecompress of claim 30, wherein the phase change material comprises highdensity polyurethane foam.
 40. The compress of claim 30, wherein theouter shell is configured as an eye mask having first and secondeye-covering lobes, each of the first and second eye-covering lobescomprising at least one internal enclosure containing the first andsecond fill materials.
 41. The compress of claim 30, further comprisingat least one attachment portion attached to the outer shell for holdingthe external contact surface in contact with the body part.